Gradalis, Inc., announced that the FDA has granted the company’s personalized investigational cellular immunotherapy, Vigil® (Gemogenovatucel-T) Regenerative Medicine Advanced Therapy (RMAT) designation based on favorable clinical results from the ongoing Phase 2b VITAL trial. Vigil is being developed as a maintenance treatment for women with newly diagnosed, advanced Stage IIIb/IV ovarian cancer who are homologous recombination proficient (HRP), have a high clonal tumor mutation burden (cTMB-H) and who are in complete response after debulking surgery and frontline platinum-based doublet chemotherapy. This recognition underscores the potential value for Vigil to address a critical unmet need in this patient population.
RMAT designation is reserved for advanced cellular and engineered therapies that show potential to address serious or life-threatening conditions based on preliminary clinical evidence. The designation provides benefits such as increased FDA interactions and guidance on efficient product development. RMAT designated products may qualify for FDA approval pathways that could expedite the delivery of Vigil to cancer patients.
Vigil is a first in class immunotherapy designed to target clonal mutation signals which are contained within all cancer cells, setting it apart from other treatments that focus on sub-clonal signals. Receipt of RMAT designation was based on analysis of promising clinical results from the VITAL study that demonstrated clinically meaningful and statistically significant overall survival benefits in patients with HRP ovarian cancer and cTMB-H who achieved complete response after standard of care frontline therapy.
“The RMAT designation for Vigil highlights the transformative capacity of our unique immunotherapy to benefit women battling advanced ovarian cancer,” said David Shanahan, CEO of Gradalis. “This important recognition affirms that Vigil has the potential to extend patient survival and may offer a safer, more precise therapeutic approach to a population in urgent need of innovative solutions. We continue to advance our Vigil development efforts as we work to bring this investigational therapy to patients as rapidly as possible.”
Ovarian cancer remains one of the deadliest cancers among women, with a lifetime risk of 1 in 87. Standard treatments, such as surgery and chemotherapy, often yield initial responses, but up to 75% of patients experience disease recurrence within two years. For women with HRP ovarian cancer, current treatment options are even less effective, with significantly shorter progression-free survival compared to other molecular profiles. Despite advancements, no current therapies have shown meaningful clinical benefits for this subgroup, leaving a critical gap in care.
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